Anavex Life Sciences Corp. (“Anavex” or the “Company”)
(Nasdaq:AVXL), a clinical-stage biopharmaceutical company
developing differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases including
Alzheimer’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported results of the entire genome DNA and
RNA evaluation of study participants in a 57-week Phase 2a
Alzheimer’s disease study investigating ANAVEX®2-73, a selective
sigma-1 receptor agonist, resulting in the analysis of 33,311 genes
and 860 pathways. Additionally, direct target occupancy of
ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron
emission tomography (PET) scanning was presented.
Several genetic variants that impacted response
to ANAVEX®2-73 were identified in the study analysis including the
Sigma-1 receptor (SIGMAR1), the target for ANAVEX®2-73, and the
Catechol-O-methyltransferase (COMT) gene, produced by nerve cells
and involved in memory function. Results showed that study
participants with SIGMAR1 (rs1800866) or COMT
(rs113895332/rs61143203) variants were less likely to benefit from
treatment with ANAVEX®2-73. In the study population, when
participants with these variants (approximately 20 percent) were
excluded, the remaining study participants (approximately 80
percent) showed improved scores on gold-standard tests of cognition
(MMSE) and activities of daily living (ADCS-ADL) (p<0.05).
- Including participants with milder disease (baseline MMSE ≥20)
and excluding those with a SIGMAR1 variant resulted in an average
improvement of +1.7 MMSE and +3.9 ADCS-ADL at week 57 compared to
baseline.
- The additional exclusion of participants with the COMT variant
resulted in a score improvement of +2.0 MMSE and +4.9 ADCS-ADL at
week 57 compared to baseline.
“This is the first full genomic analysis of
ANAVEX®2-73 in Alzheimer’s disease which resulted in the
identification of actionable genetic variants, bringing us one step
closer to realizing the full potential of a precision medicine and
precision pharmacology approach to treating this devastating
disease,” said Professor Harald Hampel, M.D., Ph.D., MA, MSc, AXA
Research Fund & Sorbonne University Excellence Chair,
Department of Neurology, Sorbonne University, Paris. He is the
speaker of the Alzheimer Precision Medicine Initiative (APMI).
Professor Hampel continues that “We look forward to advancing the
ANAVEX®2-73 program and believe that a biomarker-guided approach to
targeted drug development that allows to select those patients who
will respond best to treatment will result in improved clinical
results.”
The presentations at AAIC 2018:
- Sigma-1 Receptor Target Occupancy Study with Dynamic PET Scan
Analysis of ANAVEX®2-73, a Clinical Candidate for Neurodegenerative
and Neurodevelopmental Diseases (P4-262)1
- Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s
Disease Study Identifies Biomarkers Enabling Targeted Therapy and a
Precision Medicine Approach (P4-206)2
- Systematic Processing of Full Genomic Analysis of ANAVEX®2-73
Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a
Precision Medicine Approach (DT-01-05)3
“The innovative study findings based on
ANAVEX®2-73 moves precision medicine and pharmacology a step closer
in Alzheimer’s therapy trials,” said Christopher U. Missling,
Ph.D., President and Chief Executive Officer of Anavex. “We
continue to focus on the effect of ANAVEX®2-73 leveraging this
approach to drug development to provide intelligent solutions
beyond many traditional neurology trials to disease areas with high
unmet needs.”
About ANAVEX®2-73
ANAVEX®2-73 activates the Sigma-1 receptor (S1R)
protein, which serves as a molecular chaperone and functional
modulator involved in restoring homeostasis. S1R activation has
demonstrated the ability to reduce key pathophysiological signs of
Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and
inflammation. In a previous Phase 2a Alzheimer’s disease study,
ANAVEX®2-73 showed dose dependent improvements in exploratory
endpoints of cognition (MMSE) and function (ADCS-ADL). A full
genomic analysis of those Phase 2a Alzheimer’s disease patients was
also performed. In addition, the initiation of a 48-week Phase 2b/3
study of ANAVEX®2-73 in early Alzheimer’s disease and a 14-week
Phase 2 study of ANAVEX®2-73 in Parkinson’s disease dementia have
just been approved. Both studies will incorporate the biomarkers
presented at AAIC 2018.
Professor Harald Hampel, MD, PhD, MA,
MSc
Professor Harald Hampel is Full Professor and
AXA research fund and Sorbonne University Excellence Chair at
Sorbonne University, Departments of Neurology and Neuroscience,
Paris, France.
He is principal investigator and speaker of the
Alzheimer Precision Medicine Initiative and of the Cholinergic
Systems Working Group and Senior Associate Editor of the journal of
the Alzheimer Association, "Alzheimer's & Dementia".
He published more than 700 peer-reviewed
research papers and edited 8 books, won multiple awards for his
research focusing on brain health & disease, biomarker and
therapy discovery in Alzheimer's disease. He holds
international research grants and is principal investigator of
research consortia.
About the Alzheimer’s Disease Precision
Medicine Initiative (APMI)
The Alzheimer’s Disease Precision Medicine
Initiative (APMI), established in 2016, is an international
consortium of scientists aimed to facilitate reforms in the
conceptualization of Neurological diseases, such as Alzheimer’s,
away from a traditional one-size fits all approach to drug
development towards individualized biomarker-guided targeted
therapy for the right patient at the right
time.https://www.ncbi.nlm.nih.gov/pubmed/?term=Alzheimer+Precision+Medicine+Initiative
________________________
1 Samantha T. Reyes1, Scarlett G. Guo1, Jessa B. Castillo1,
Berend van der Wildt1, Aimara P. Morales1, Jun Hyung Park1,
Nell Rebowe2, Jeffrey Sprouse2, Christopher U. Missling2, Frederick
T. Chin1; 1Department of Radiology, Stanford University School
of Medicine, Stanford, CA, 2Anavex Life Sciences Corp., New
York, NY2 Harald Hampel, MD1, Mohammad Afshar, MD, PhD2,
Frédéric Parmentier, PhD2, Coralie Williams, MSc2, Adrien Etcheto,
MSc2, Federico Goodsaid, PhD3, Emmanuel O Fadiran, PhD4,
Christopher U Missling, PhD4; 1AXA Research Fund & UPMC Chair,
Paris, France; Sorbonne Universites Pierre et Marie Curie (UPMC),
Paris, France, 2Ariana Pharma, Paris, France, 3Regulatory
Pathfinders LLC, San Francisco, CA, 4Anavex Life Sciences Corp.,
New York, NY3 Harald Hampel, MD1, Mohammad Afshar, MD, PhD2,
Frédéric Parmentier, PhD2, Coralie Williams, MSc2, Adrien Etcheto,
MSc2, Federico Goodsaid, PhD3, Emmanuel O Fadiran, PhD4,
Christopher U Missling, PhD4; 1AXA Research Fund & UPMC Chair,
Paris, France; Sorbonne Universites Pierre et Marie Curie (UPMC),
Paris, France, 2Ariana Pharma, Paris, France, 3Regulatory
Pathfinders LLC, San Francisco, CA, 4Anavex Life Sciences Corp.,
New York, NY
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX®2-73, recently completed a successful Phase 2a clinical
trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available
drug candidate that restores cellular homeostasis by targeting
sigma-1 and muscarinic receptors. Preclinical studies demonstrated
its potential to halt and/or reverse the course of Alzheimer’s
disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic,
neuroprotective and anti-depressant properties in animal models,
indicating its potential to treat additional CNS disorders,
including epilepsy. The Michael J. Fox Foundation for Parkinson’s
Research previously awarded Anavex a research grant, which fully
funded a preclinical study to develop ANAVEX®2-73 for the treatment
of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1
muscarinic receptors, is a promising preclinical drug candidate
demonstrating disease-modifying activity against the major
hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice,
including cognitive deficits, amyloid and tau pathologies. In
preclinical trials, ANAVEX®3-71 has shown beneficial effects on
neuroinflammation and mitochondrial dysfunction. Further
information is available at www.anavex.com. You can also connect
with the company
on Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors:Scott GordonCore
IRscottg@coreir.com
Media:Melyssa WeibleElixir Health Public
Relations201-723-5805mweible@elixirhealthpr.com
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